Real-World Evidence on the Safety and Efficacy of Adjunctive Perampanel Across Different Geographical Regions from Three Phase IV Studies: Studies 506, 508, and 501
Abstract number :
3.276
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825630
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Authors :
Robert Wechsler, MD, PhD - Idaho Comprehensive Epilepsy Center; Antonietta Coppola, MD, PhD - Federico II University; Anshu Rohatgi, MD - Sir Ganga Ram Hospital; Anna Patten, PhD - Eisai Europe Ltd.; Samantha Goldman, MD, B. Sc (Hons) - Eisai Europe Ltd.; Anna Gentile, PhD - Eisai S.r.l., Epilepsy; Balaji Patil, MD - Eisai Pharmaceuticals India Pvt., Ltd.; Amitabh Dash, MD, MBBS - Eisai Singapore Pte., Ltd.; Leock Y. Ngo, PhD - Eisai Inc.; Manoj Malhotra, MD - Eisai Inc.
Rationale: Perampanel is a once-daily oral anti-seizure medication for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), and generalized tonic-clonic seizures. Real-world studies complement randomized controlled trials and allow evaluation of efficacy and safety of a drug during routine clinical care. We report data from three Phase IV studies (PROVE 506 [US; NCT03208660], 508 [India; NCT03836924], and 501 [Italy; NCT04257604]) to assess real-world use of adjunctive perampanel across different geographical regions.
Methods: Studies 506, 508, and 501 were Phase IV, multicenter, post-approval observational studies in patients with epilepsy (any seizure type; Study 506), or specifically, FOS with/without FBTCS (Studies 508/501). In Study 506, data were obtained retrospectively from medical records of patients who initiated perampanel after Jan-01-14; enrollment completed on Mar-15-19. Study 508 comprised a Screening/Enrollment Visit, 6-month Treatment Period (monthly clinical visits), and 30-day Follow-up Period. Study 501 was a long-term (12-month) study with mandatory clinical visits at 3, 6, and 12 months of treatment. Endpoints included: retention rate (Studies 506/501), median percent reduction in seizure frequency/28 days, 50% responder and seizure-freedom rates, and treatment-emergent adverse events (TEAEs) (all studies).
Results: In Study 506, 1703 patients received perampanel (mean [standard deviation (SD)] age: 28.5 [16.5] years); mean (SD) perampanel dose: 5.6 (2.7) mg/day. Retention rate at 12 months was 58.5% (n=876/1498). At Months 10–12, median percent reduction in seizure frequency/28 days was 75.0% (n=123; Figure 1A), 50% responder rate was 62.6% (n=77/123), and seizure-freedom rate was 30.9% (n=38/123).
In Study 508, 200 patients received perampanel (mean [SD] age: 28.7 [12.4] years); mean (SD) perampanel dose: 4.0 (1.8) mg/day. At the end of the 6-month Treatment Period, median percent reduction in seizure frequency/28 days was 100.0% (n=174; Figure 1B), 50% responder rate was 83.3% (n=145/174), and seizure-freedom rate was 49.4% (n=86/174).
In Study 501, 234 patients received perampanel (mean [SD] age: 38.6 [16.7] years); mean (SD) perampanel dose: 5.4 (2.0) mg/day. Retention rate at 12 months was 57.3% (n=134/234). At 12 months, median percent reduction in seizure frequency/28 days was 82.2% (n=109; Figure 1C), 50% responder rate was 75.2% (n=82/109), and seizure-freedom rate was 25.5% (n=28/110).
TEAEs occurred in 704/1703 (41.3%; Study 506) patients, 36/199 (18.1%; Study 508) patients, and 132/234 (56.4%; Study 501) patients. The most common TEAE was dizziness/vertigo and < 25% of patients, across all studies, discontinued treatment due to TEAEs (Table 1).
Conclusions: These data suggest that perampanel is efficacious and well tolerated during real-world use regardless of geographical region and sample size; no unexpected safety signals emerged.
Funding: Please list any funding that was received in support of this abstract.: Eisai Inc., Eisai Pharmaceuticals India Pvt., Ltd., and Eisai s.r.l.
Anti-seizure Medications